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Practical and Science-Based Strategy for Establishing Acceptable Intakes for Drug Product N‑Nitrosamine Impurities

Chemical research in toxicology, 2022-03, Vol.35 (3), p.475-489

2022

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Potential for the Formation of N‑Nitrosamines during the Manufacture of Active Pharmaceutical Ingredients: An Assessment of the Risk Posed by Trace Nitrite in Water

Organic process research & development, 2020-09, Vol.24 (9), p.1629-1646

2020

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Formation of Dialkyl‑N‑nitrosamines in Aqueous Solution: An Experimental Validation of a Conservative Predictive Model and a Comparison of the Rates of Dialkyl and Trialkylamine Nitrosation

Organic process research & development, 2023-10, Vol.27 (10), p.1759-1766

2023

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A Consideration of the Extent That Tertiary Amines Can Form N‑Nitroso Dialkylamines in Pharmaceutical Products

Organic process research & development, 2023-10, Vol.27 (10), p.1714-1718

2023

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Regioselective synthesis of 4-(2-alkyl-5-methyl-2 H-pyrazol-3-yl)-piperidines

Tetrahedron letters, 2006-03, Vol.47 (11), p.1729-1731

2006

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Approaches and Considerations for the Investigation and Synthesis of N‑Nitrosamine Drug Substance-Related Impurities (NDSRIs)

Organic process research & development, 2023-10, Vol.27 (10), p.1784-1791

2023

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Nitrite in Pharmaceutical Manufacturing Water: Development of an Ultra-Sensitive Analytical Method, Typical Data, and Discussion of Potential Nitrosamine Formation in Drug Substance and Drug Product from Water

Organic process research & development, 2024-06

2024

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Considerations for Starting Material Designation for Drug-Linkers in Antibody–Drug Conjugates

Organic process research & development, 2023-07, Vol.27 (7), p.1269-1275

2023

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FDA/M-CERSI Co-Processed API Workshop Proceedings

Journal of pharmaceutical sciences, 2023-08, Vol.112 (8), p.2069-2078

2023

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Impact of ICH Q11 Questions and Answers on the Outcome of Active Pharmaceutical Ingredient Starting Material Proposal Acceptance by ICH Regulatory Members

Organic process research & development, 2024-04

2024

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Oxazoline N-Oxide-Mediated [2 + 3] Cycloadditions: Application to a Total Synthesis of the Hypocholesterolemic Agent 1233A

Journal of organic chemistry, 1998-09, Vol.63 (19), p.6634-6642

1998

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Development of an Intrinsically Safer Methanolysis/Aromatic Nitro Group Reduction for Step 1 and 2 of Talazoparib Tosylate

Organic process research & development, 2021-12, Vol.25 (12), p.2686-2692

2021

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Callipeltoside A: Total Synthesis, Assignment of the Absolute and Relative Configuration, and Evaluation of Synthetic Analogues

Journal of the American Chemical Society, 2002-09, Vol.124 (35), p.10396-10415

2002

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Statistical tools to aid in the assessment of critical process parameters

Pharmaceutical technology Europe, 2016-03, Vol.28 (3), p.22

2016

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Callipeltoside A: Assignment of Absolute and Relative Configuration by Total Synthesis

Angewandte Chemie (International ed.), 2002-03, Vol.41 (5), p.841-843

2002

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The Lactol Route to Fesoterodine: An Amine-Promoted Friedel–Crafts Alkylation on Commercial Scale

Organic process research & development, 2011-09, Vol.15 (5), p.1010-1017

2011

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Callipeltoside A: Assignment of Absolute and Relative Configuration by Total Synthesis

Angewandte Chemie, 2002-03, Vol.114 (5), p.869-871

2002

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NK1 antagonists based on seven membered lactam scaffolds

Bioorganic & medicinal chemistry letters, 2006-06, Vol.16 (11), p.2929-2932

2006

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Expeditious synthesis of novel NK1 antagonists based on a 1,2,4-trisubstituted cyclohexane

Tetrahedron letters, 2006-02, Vol.47 (8), p.1295-1298

2006

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An Asymmetric Synthesis of C-2-epi-Hygromycin A

Angewandte Chemie (International ed.), 2001-10, Vol.40 (19), p.3658-3660

2001

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A new route to C-glycosylidene compounds mediated by olefin metathesis

Tetrahedron letters, 1999-06, Vol.40 (26), p.4801-4802

1999

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Application of the AAA Reaction to the Synthesis of the Furanoside of C-2-epi-Hygromycin A: A Total Synthesis of C-2-epi-Hygromycin A

Chemistry : a European journal, 2002-01, Vol.8 (1), p.259-268

2002

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Expeditious synthesis of novel NK 1 antagonists based on a 1,2,4-trisubstituted cyclohexane

Tetrahedron letters, 2006, Vol.47 (8), p.1295-1298

2006

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Double diastereoselection in asymmetric [2+3] cycloaddition of chiral oxazoline N-oxides: application to the kinetic resolution of a racemic α,β-unsaturated δ-lactone

Tetrahedron: asymmetry, 1999-08, Vol.10 (16), p.3197-3207

1999

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Callipeltoside A: Assignment of Absolute and Relative Configuration by Total Synthesis We thank the National Science Foundation and the National Institutes of Health for their generous support of our programs. OD was supported in part by a fellowship from the Association pour la Recherche contre le Cancer (ARC). J.L.G. was supported in part by a NIH postdoctoral fellowship from the National Cancer Institute. Mass spectra were provided by the Mass Spectroscopy Facility at the University of Califo

Angewandte Chemie International Edition, 2002-03, Vol.41 (5), p.841

2002

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Practical and Science-Based Strategy for Establishing Acceptable Intakes for Drug Product N‑Nitrosamine Impurities

Potential for the Formation of N‑Nitrosamines during the Manufacture of Active Pharmaceutical Ingredients: An Assessment of the Risk Posed by Trace Nitrite in Water

Formation of Dialkyl‑N‑nitrosamines in Aqueous Solution: An Experimental Validation of a Conservative Predictive Model and a Comparison of the Rates of Dialkyl and Trialkylamine Nitrosation

A Consideration of the Extent That Tertiary Amines Can Form N‑Nitroso Dialkylamines in Pharmaceutical Products

Regioselective synthesis of 4-(2-alkyl-5-methyl-2 H-pyrazol-3-yl)-piperidines

Approaches and Considerations for the Investigation and Synthesis of N‑Nitrosamine Drug Substance-Related Impurities (NDSRIs)

Nitrite in Pharmaceutical Manufacturing Water: Development of an Ultra-Sensitive Analytical Method, Typical Data, and Discussion of Potential Nitrosamine Formation in Drug Substance and Drug Product from Water

Considerations for Starting Material Designation for Drug-Linkers in Antibody–Drug Conjugates

FDA/M-CERSI Co-Processed API Workshop Proceedings

Impact of ICH Q11 Questions and Answers on the Outcome of Active Pharmaceutical Ingredient Starting Material Proposal Acceptance by ICH Regulatory Members

Oxazoline N-Oxide-Mediated [2 + 3] Cycloadditions: Application to a Total Synthesis of the Hypocholesterolemic Agent 1233A

Development of an Intrinsically Safer Methanolysis/Aromatic Nitro Group Reduction for Step 1 and 2 of Talazoparib Tosylate

Callipeltoside A: Total Synthesis, Assignment of the Absolute and Relative Configuration, and Evaluation of Synthetic Analogues

Statistical tools to aid in the assessment of critical process parameters

Callipeltoside A: Assignment of Absolute and Relative Configuration by Total Synthesis

The Lactol Route to Fesoterodine: An Amine-Promoted Friedel–Crafts Alkylation on Commercial Scale

Callipeltoside A: Assignment of Absolute and Relative Configuration by Total Synthesis

NK1 antagonists based on seven membered lactam scaffolds

Expeditious synthesis of novel NK1 antagonists based on a 1,2,4-trisubstituted cyclohexane

An Asymmetric Synthesis of C-2-epi-Hygromycin A

A new route to C-glycosylidene compounds mediated by olefin metathesis

Application of the AAA Reaction to the Synthesis of the Furanoside of C-2-epi-Hygromycin A: A Total Synthesis of C-2-epi-Hygromycin A

Expeditious synthesis of novel NK 1 antagonists based on a 1,2,4-trisubstituted cyclohexane

Double diastereoselection in asymmetric [2+3] cycloaddition of chiral oxazoline N-oxides: application to the kinetic resolution of a racemic α,β-unsaturated δ-lactone

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